“My moment of epiphany came while attending the 2008 Drupal Conference. It was then that the potential of bringing open source software to the life sciences industry hit me,” recalls Max Kanevsky, CEO, Pinnacle 21. At that time, CDISC organization was gaining traction among pharmaceutical and biotechnology companies attempting to standardize their clinical trial data for regulatory submissions. Kanevsky saw the need to validate the standardization and his efforts culminated in an open-source validator, Pinnacle 21 Community.

Fast-forward to December 2016, when the U.S. FDA mandated submission of clinical trial data in conformance with CDISC standards. Kanevsky and Pinnacle 21 were now positioned to help the industry to prepare and health authorities (US FDA and Japan’s PMDA) to review submission data using Pinnacle 21 Enterprise, the commercial version of the tool. Pinnacle 21 Enterprise has now become an integral part of FDA’s 21st Century Review Initiative, ensuring that submission data is compliant, useful and ready for review. “The entire industry, from CROs to biotechs to big pharma to health authorities, are using either our Community or Enterprise tool,” explains Kanevsky.

Because Pinnacle 21 Enterprise is used by the U.S. and Japanese Health Authorities, clinical trial sponsors who use the tools have confidence in getting the data ready for submission. This allows them to proactively anticipate potential questions about their data, decreasing the time required for the traditional “back and forth” of questions and answers. The result is improved data integrity and a more easily reviewed submission package.

The entire industry, from CROs to biotechs to big pharma to health authorities, are using either our Community or Enterprise tool

There is currently no other software on the market that addresses all of the complexities of preparing clinical data on the sponsor side and then validating clinical data on the health authority side. The broad adoption by the industry and health authorities is further proof of the benefits and solutions these products provide.

Pinnacle 21 Enterprise provides the ability to manage long, complex and compliance-driven data standardization processes from protocol design through regulatory submission. Enterprise also supports oversight and collaboration with CROs. Kanevsky explains, “Life Sciences companies who outsource their clinical trials to CROs, utilize Pinnacle 21 Enterprise to validate the data sent by the CROs. Enterprise serves as a collaborative platform for CRO and sponsor companies to identify and address issues prior to final submission to the agencies.”

To further manage compliance, Pinnacle 21 also offers additional tools that address the requirements for submission of electronic data. These include the Define.XML Designer and the Reviewer’s Guide Designer.

To illustrate his firm’s impact on the industry and the regulatory review process, Kanevsky points to a particular company who received negative feedback for its submission to the FDA. After implementing Pinnacle 21 Enterprise, the client was able to submit high-quality standardized data that was approved in approximately four months.

“We want to be the “Go-to-team” who can help you in all phases of data standardization whether it is defining your standards, validation, creating supporting documents for submission, or anything in the complex process of preparing a standardized electronic data submission package,” notes Kanevsky.

Despite Pinnacle 21 reaching the pinnacle of success with their Enterprise solution, Kanevsky believes it is just the tip of the iceberg. Electronic data standardization is still in its infancy so there is still room for expanded implementation, improvement and automation. Pointing toward reduced submission review timeframes as his ultimate vision, Kanevsky states that his team’s aim is also to compress the timeline of clinical trials wherever possible. “Imagine the huge impact on patients if we can help even one new therapy, particularly one as critical as a cancer drug, to reach the market just one month earlier.”